RECTOCELE AND CYSTOCELE DEVICE
A recto-cystocele device to address rectocele and cystocele disorder is described. The device generally comprise a handle and a paddle that are distinguished from one another by a bend in the recto-cystocele device which forms essentially an L-shaped unit, the bend possessing a sufficient radius to avoid contact with a pelvic region of the woman and the recto-cystocele device. The device further comprises an expandable sheath located on the paddle that after being inserted in a vagina of the woman and is expanded therein is in contact with at least an upper portion of the vagina that includes a posterior fornix of the vagina and a lower portion of the vagina that does not include the posterior fornix. The handle, which does not go into the vagina, is adapted to be manually manipulated by the woman to translate directional pressure against the posterior fornix and the lower portion of the vagina via the expandable sheath when expanded.
This application claims priority to and the benefit of U.S. Non-provisional Patent Application No. 13/803,890, entitled: Rectocele Device, filed on Mar. 14, 2013 the entire disclosure of which is hereby incorporated by reference, U.S. Provisional Patent Application No. 61/786,253 entitled: Cystocele Device, filed on Mar. 13, 2013, the entire disclosure of which is hereby incorporated by reference, and U.S. Provisional Patent Application No. 61/887,849 entitled: Rectocele and Cystocele Device, filed on Oct. 7, 2013, the entire disclosure of which is hereby incorporated by reference.
FIELD OF THE INVENTIONThe present invention is directed to a rectocele and cystocele device that is useful in reducing the effects of a rectocele which impair a woman's ability to move bowel and/or a cystocele which impair a woman's ability to urinate.
BACKGROUND OF THE INVENTIONRectocele 104 in a roman 100 is a condition whereby the woman's rectum is prolapsed into the posterior wall of the woman's vagina. Rectocele is defined as bulging of the front wall of the rectum (rectovaginal wall) into the vagina. Rectocele is due to weakening of the pelvic support structures and thinning of the rectovaginal wall (the tissues separating the rectum from the vagina) and is primarily a result of childbirth, chronic constipation, and hysterectomy. The rectum ballooning into the vagina is often exacerbated during a bowel movement as shown in
In an attempt to aid with a bowel movement in cases of rectocele, a woman may insert her fingers into her vagina to manually press against the rectocele, which helps create a uniform pathway for stool to move out of the rectum. Because a rectocele may protrude to the right of left of the posterior wall of the vagina, by using the sense of touch in her fingers, a woman is able to reposition her fingers to the where the rectocele occurs. In other words, a woman is able to press against the rectocele with her fingers by taking advantage of bio-feedback in her fingers.
As shown in
Though surgical procedures exist to repair rectoceles and cystoceles, in less severe cases, a number of optional devices currently exist to provide some rectocele and/or cystocele relief. One family of devices includes spoon-like devices, which are used just prior to a bowel movement to essentially when the bowel movement or urination is completed. Unlike the biofeedback of fingers to facilitate repositioning of pressure against the rectocele or the cystocele, spoon-like devices are unable to sense if a rectocele or cystocele is sliding to the right or left of the spoon. In one example, when a rectocele slides to the right or left of the spoon, the woman may press harder against her posterior rectovaginal wall with the spoon because she is not experiencing proper stool evacuation and cannot sense through bio-feedback that the rectocele has moved around the spoon, which then may cause damage to her posterior rectovaginal wall. The same problem applies to a cystocele.
Another family of devices used to address rectoceles includes pessaries, which are typically inflated balloons that provide static pressure on all surfaces of the vaginal canal (the rectovaginal wall, lateral walls and the bladdervaginal wall). Pessaries offer extended support to address rectoceles. Pessaries are not inserted into a vagina just prior to a bowel movement to the point of when a bowel movement is complete or prior to the point of urination or just when urination is complete. Rather, pessaries are left in the vagina for an extended period of time, sometimes being inserted in the morning and removed at night to being left in for days at a time, if not longer. Moreover, due to the static nature of pessaries, pessaries are unable to be manipulated to push prolapsing organs back into place once inserted in a vagina.
It is to innovations related to addressing passing a bowel movement in women suffering from a rectocele or urination in women suffering from a cystocele that the claimed invention is generally directed.
SUMMARY OF THE INVENTIONThe present invention is directed to a rectocele/cystocele device that is useful in providing pressure against the rectocele to improve bowel movements in women or against the cystocele to improve urination events in women.
Embodiment of the present invention can therefore comprise a recto-cystocele device adapted to be inserted in a vagina of a woman through a vaginal opening, the recto-cystocele device comprising: a handle; a paddle, wherein the handle and the paddle are distinguished by a bend in the recto-cystocele device which forms essentially an L-shaped unit, the bend possessing a sufficient radius to avoid contact with a pelvic region of the woman and the recto-cystocele device; and an expandable sheath located on the paddle that after being inserted in a vagina of the woman and is expanded therein is in contact with at least a cervix and a portion of the vagina, the handle, which does not go into the vagina, is adapted to be manually manipulated by the woman to translate directional pressure against the cervix and the portion of the vagina via the expandable sheath when expanded.
Embodiments of the recto-cystocele device are contemplated to include: embodiments where the bend extends between 0.5 inches and 5.0 inches from the paddle, embodiments where the bend possesses a radius of between 0.5 inches and 3.0 inches, embodiments where the directional pressure is in a direction that lifts the pelvic floor away from the vaginal opening, embodiments where the directional pressure includes all directions in three dimensions but remains in contact with the cervix, embodiments further comprising a replaceable sleeve that covers the expandable sheath during each use, embodiments where the directional pressure is in a direction that supports a uterus, a rectrouterine pouch, a rectum all associated with the woman via the vagina, embodiments where the portion is at least 50% of the vaginal cavity, embodiments where the recto-cystocele device is adapted to be used essentially from just prior to a bowel movement of the woman to just after the bowel movement, embodiments where the recto-cystocele device is adapted to be used essentially from just prior to a urination event of the woman to just after the urination event, embodiments further comprising an inflation bulb disposed on the handle that is connected to the expandable sheath by way of a tube, embodiments further comprising an inflation bulb disposed on the handle that is connected to the expandable sheath by way of a tube wherein the inflation bulb is adapted to inflate the expandable sheath with air when the inflation bulb is manually squeezed, embodiments where, embodiments where the L-shaped unit possesses an angle that is essentially ninety degrees between the handle and the paddle, embodiments where the expandable sheath extends to at least the distal end of the paddle, embodiments where the expandable sheath is manually expanded and contracted, embodiments further comprising an inflation bulb connected to the handle via a flexible tube wherein a continuous pathway is formed between the inflation bulb and the expandable sheath.
Another embodiment of the present invention can therefore comprise a device to assist stool evacuation and urine voiding, the device comprising: a handle and a paddle, the handle and the paddle are delineated by a bend in the device; and an expandable sheath located on the paddle, the paddle adapted to be inserted through a vaginal opening in a vagina of a woman wherein the expandable sheath is expanded inside of the vagina to contact at least a cervix and a portion of the vagina, the handle adapted to be manipulated by the woman to lift the pelvic floor away from the vaginal opening via the expandable sheath when expanded, the handle not adapted to go in the vagina.
Embodiments of the device to assist stool evacuation and urine voiding are contemplated to include: embodiments where the handle adapted to not be in contact with a pelvic region of the woman, embodiments where the portion is at least 50% of the vagina, embodiments where the bend possesses a radius that extends sufficiently from the paddle to avoid contact with the pelvic region of the woman, embodiments where the handle and the paddle forms essentially an L-shaped unit, embodiments where the device is adapted to be used essentially from just before a bowel movement of the woman to just after the bowel movement or essentially from just before a urination event of the woman to just after the urination event which can further comprising a replaceable sleeve that covers the expandable sheath during each use and then can further comprising a means to retain the replaceable sleeve on the paddle.
Yet another embodiment of the present invention can therefore comprise a method to ease a defecation event or a urination event in a woman wherein the woman solely performs the method on herself, the method comprising: providing a rectocele/cystocele device possessing: a handle, a paddle wherein the handle and the paddle are delineated by a bend in the rectocele/cystocele device, and an expandable sheath disposed on the paddle; holding the handle; inserting the paddle and expandable sheath through a vaginal opening in a vagina of the woman prior to the defecation or the urination event when the woman experiences a desire to defecate or urinate wherein the handle remains outside of the vagina; expanding the sheath in the vagina; moving the expandable sheath in a first position to be in contact with a cervix of the woman and a portion of the vagina; manipulating the handle to adjust the cervix and the portion of the vagina in a second position via the expandable sheath wherein the handle avoids contact with a pelvic region of the woman; and withdrawing the paddle and expandable sheath from the vaginal opening following the defecation or the urination event.
Embodiments of the method to ease a defecation event or a urination event in a woman can further include: embodiments where the inserting step is performed within five minutes of the defecation or the urination event and the withdrawing step is performed within five minutes of the defecation or the urination event, embodiments further comprising covering the expandable sheath with an unused replaceable sleeve, embodiments further comprising manually expanding the sheath by squeezing a bulb located at the distal end of the handle.
Further embodiments contemplate a sheath possessing dual balloons or several sheaths wherein one balloon (or sheath) is in contact with a woman's posterior fornix (including cervix when present) and another balloon (or sheath) is in contact with a different part of the vaginal wall that does not include the posterior fornix.
Initially, this disclosure is by way of example only, not by limitation. Thus, although the instrumentalities described herein are for the convenience of explanation, shown and described with respect to exemplary embodiments, it will be appreciated that the principles herein may be applied equally in other types of situations involving holding back rectoceles.
To illustrate an exemplary environment in which preferred embodiments of the present invention can be practiced,
Consistent with embodiments of the present invention,
Certain embodiments contemplate the rectocele device 200 being used essentially from just prior to a bowel movement of a woman to just after the bowel movement of the woman. By using the rectocele device 200 for essentially just a bowel movement, a woman can live free from a foreign object in her vagina 106 during her normal daily activities. Hence, when a woman needs to move stool, she inserts the paddle 204 in her vagina 106 and expands the expandable sheath 202, such as, for example, by squeezing the air out of the inflation bulb 210. The expandable sheath when expanded is in contact with the woman's rectovaginal wall 102. During operation, the handle 206 remains outside of the vagina 106 at essentially where the bend 208 is located. The handle 206 translates directional pressure on the rectovaginal wall 102 by way of the paddle 204 when the handle 206 is in manually pulled towards the woman's belly button 116. More specifically, the handle 206 is used as a lever rotating about the mons veneris 120, thus pushing back the rectocele 104 by way of the paddle 204 and expandable sheath 202 pushing against the rectovaginal wall 102. When the woman has completed moving stool, she contracts the expandable sheath 202, such as, for example, by releasing the inflation bulb 210, and withdraws the paddle 204 from her vagina 106.
Certain embodiments contemplate the expandable sheath 202 being in contact with the rectovaginal wall 102 and lateral walls (not shown) of the vagina 106, but not in contact with the bladdervaginal wall 110. By being in contact with the at least a portion of the lateral walls of the vagina 106 and the rectovaginal wall 102, the expandable sheath 202 helps control the rectocele 104 from sliding around the side of (to the right or left) the paddle 204. Accordingly, the rectocele 104 is adequately compressed to allow the stool to evacuate effectively with the rectocele device 200.
Also, depicted in
As depicted in
With further reference to the rectocele/cystocele device 900, the bend 208 possesses a bend radius 908 that provides clearance around the pelvic region 1030. This clearance makes it possible to avoid contacting the handle 206 with the pelvic region 1030, thus facilitating freedom without obstruction to adjust the expandable sheath 702 upwards, from side to side, posterior, anterior, etc., to improve urinating or defecating. As depicted, the handle 206 is manipulated towards the woman's belly button 116 in an upwards direction 1004, thus translating the pressure directionally upwards 1008 against the cervix 1006, rectouterine pouch 1012, and vaginal wall 103 via the expandable sheath 702 when expanded. Optional embodiments contemplate a small radial bend 208 between the handle 206 and the paddle 204 wherein the paddle 204 is sufficiently long enough to accomplish the same goal of providing enough clearance between the handle and the pelvic region 1030 to avoid contact during use.
Certain embodiments consistent with
Further embodiments of the first balloon portion 1402 and the second balloon portion 1404 include independent sheaths. Other embodiments contemplate the first balloon portion 1402 and the second balloon portion 1404 possessing elastic material (rubber, for example) having different durameter stiffness. For example, the second balloon portion 1404 may be made of an elastic material with a higher durameter than the first balloon portion 1402. Optionally, the second balloon portion 1404 may be made of the same elastic material as the first balloon portion 1402, but only thicker thus creating a stiffer balloon (or vise-versa). Other embodiments contemplate more air pressure (fluid pressure) applied to the second balloon 1404 than the first balloon 1402. Yet other optional embodiments contemplate the first balloon portion 1402 never touching the second balloon portion 1404.
Other embodiments to inflate the first balloon portion 1402 and the second balloon portion 1404 include a single passageway with a first outlet leading to the first balloon portion 1402 and a second outlet leading to the second balloon portion 1404 with backflow valves that that can be released by a release valve or other mechanism. Yet other embodiments contemplate inflating the first balloon portion 1402 and the second balloon portion 1404 with independent inflation sources (dual bulbs 210, for example).
It is to be understood that even though numerous characteristics and advantages of various embodiments of the present invention have been set forth in the foregoing description, together with the details of the structure and function of various embodiments of the invention, this disclosure is illustrative only, and changes may be made in detail, especially in matters of structure and arrangement of parts within the principles of the present invention to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed. For example, additional expansion elements/devices to expand the expandable sheath can be used in a consistent manner with embodiments of the present invention while still maintaining substantially the same functionality without departing from the scope and spirit of the present invention. Another example can include various additional devices (manual, motorize, pneumatic, etc) used to expand or contract the expandable sheath without departing from the scope and spirit of the present invention. Yet, other embodiments can include multiple sheaths to accomplish the end result without departing from the scope and spirit of the present invention. The preferred embodiments described herein are directed to a rectocele device and a cystocele device, which accordingly is not intended for uses beyond the scope and spirit of addressing a rectocele or cystocele of a woman.
It will be clear that the claimed invention is well adapted to attain the ends and advantages mentioned as well as those inherent therein. While presently preferred embodiments have been described for purposes of this disclosure, numerous changes may be made which readily suggest themselves to those skilled in the art and which are encompassed in the spirit of the claimed invention disclosed and as defined in the appended claims. Accordingly, it is to be understood that even though numerous characteristics and advantages of various aspects have been set forth in the foregoing description, together with details of the structure and function, this disclosure is illustrative only, and changes may be made in detail, especially in matters of structure and arrangement to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed.
Claims
1. A recto-cystocele device adapted to be inserted in a vagina of a woman through a vaginal opening, the recto-cystocele device comprising:
- a handle;
- a paddle, wherein the handle and the paddle are distinguished by a bend in the recto-cystocele device which forms essentially an L-shaped unit, the bend possessing a sufficient radius to avoid contact with a pelvic region of the woman and the recto-cystocele device;
- at least one expandable sheath located on the paddle that after being inserted in a vagina of the woman and is expanded therein is in contact with at least an upper portion of the vagina that includes a posterior fornix of the vagina and a lower portion of the vagina that does not include the posterior fornix, the handle, which does not go into the vagina, is adapted to be manually manipulated by the woman to translate directional pressure against the posterior fornix and the lower portion of the vagina via the expandable sheath when expanded.
2. The recto-cystocele device of claim 1 wherein the bend extends between 0.5 inches and 5.0 inches from the paddle.
3. The recto-cystocele device of claim 1 wherein the bend possesses a radius of between 0.5 inches and 3.0 inches.
4. The recto-cystocele device of claim 1 wherein the directional pressure is in a direction that lifts the posterior fornix away from the vaginal opening.
5. The recto-cystocele device of claim 1 wherein the directional pressure includes all directions in three dimensions but remains in contact with the posterior fornix.
6. The recto-cystocele device of claim 1 further comprising a replaceable sleeve that covers the expandable sheath during each use.
7. The recto-cystocele device of claim 1 wherein the directional pressure via the vagina is in a direction that supports a uterus, a rectrouterine pouch, a rectum all associated with the woman to mitigate organ prolapse in the woman.
8. The recto-cystocele device of claim 1 wherein the recto-cystocele device is adapted to be used essentially from just prior to a bowel movement of the woman to just after the bowel movement or just prior to urination to just after urination.
9. The recto-cystocele device of claim 1 further comprising a means for expanding the expandable sheath.
10. The recto-cystocele device of claim 1 wherein the L-shaped unit possesses an angle that is essentially ninety degrees between the handle and the paddle.
11. The recto-cystocele device of claim 1 wherein the expandable sheath extends to at least the distal end of the paddle.
12. The recto-cystocele device of claim 1 wherein said expandable sheath comprises a first balloon portion that is disposed on said paddle between said bend and the distal end of said paddle wherein said first balloon portion is in contact with the lower portion of the vagina when inflated and a second balloon portion that is disposed on said paddle and extends beyond the distal end of said paddle is in contact with the fornix region of the vagina when inflated.
13. The recto-cystocele device of claim 12 wherein only the second balloon portion contacts the posterior fornix when expanded.
14. The recto-cystocele device of claim 12 wherein the first balloon portion extends from beyond the bend to no less than one half of an inch from the distal end of the paddle and the second balloon portion extends at least one half of an inch beyond the distal end of the paddle.
15. The recto-cystocele device of claim 12 wherein the first balloon portion and the second balloon portion are separated by an essentially non-expandable section.
16. A device to assist stool evacuation and urine voiding, the device comprising:
- a handle and a paddle, the handle and the paddle are delineated by a bend in the device;
- an expandable sheath located on the paddle, the paddle adapted to be inserted through a vaginal opening in a vagina of a woman wherein the expandable sheath is expanded inside of the vagina to contact at least a fornix of the vagina and a portion of the vagina that does not include the fornix, the handle adapted to be manipulated by the woman to lift the fornix away from the vaginal opening via the expandable sheath when expanded, the handle not adapted to go in the vagina.
17. The device of claim 16 wherein the handle adapted to not be in contact with a pelvic region of the woman.
18. The device of claim 16 wherein the expandable sheath comprises a first balloon portion that is in contact with the fornix of the vagina and a second balloon portion that is in contact with the portion of the vagina that does not include the fornix.
19. The device of claim 16 wherein the handle and the paddle forms essentially an L-shaped unit.
20. A recto-cystocele device adapted to be inserted in a vagina of a woman through a vaginal opening, the recto-cystocele device comprising:
- a handle;
- a paddle, wherein the handle and the paddle are distinguished by a bend in the recto-cystocele device which forms essentially an L-shaped unit, the bend possessing a sufficient radius to avoid contact with a pelvic region of the woman and the recto-cystocele device;
- a first expandable balloon located on the paddle between the bend and at least one half of an inch shy of the distal end of the paddle and a second expandable balloon that extends beyond the distal end of the paddle, wherein after the paddle has been inserted in a vagina of the woman and the first and the second expandable balloons are expanded in the vagina, the second expandable balloon is in contact with at least a fornix of the vagina and the first expandable balloon is in contact with a portion of the vagina that does not include the fornix, the handle, which does not go into the vagina, is adapted to be manually manipulated by the woman to translate directional pressure against the fornix via the second expandable balloon and the portion of the vagina that does not include the fornix via the second expandable balloon when expanded.
Type: Application
Filed: Mar 12, 2014
Publication Date: Sep 18, 2014
Patent Grant number: 9216105
Inventors: Ryan Maaskamp (San Francisco, CA), Armand Maaskamp (Napa, CA), Gervasio Salgado (Marbella)
Application Number: 14/205,939
International Classification: A61F 6/12 (20060101);